1. Field of the Invention
The present invention relates to a device for the treatment of morbid obesity and, in particular, it relates to a reversible gastric banding device that encircles and compresses a portion of the stomach to form a stoma opening of reduced diameter, the reversible feature permitting removal of the device without the necessity of major surgery.
2. Definitions
"Reversible gastric band" as used herein, shall mean a gastric band which may be removed from an encircling position around the stomach without major surgery.
"Stoma-Adjustable gastric band" as used herein, shall mean a gastric band which may be adjusted to vary the diameter of the stoma opening within that portion of the stomach encircled by the band.
3. Description of the Prior Art
Morbid obesity is a condition that is associated with a multitude of other hazards to health that include socio-psychologic problems and reduced life expectancy. Dietary management of morbid obesity has not been successful as a long term treatment. Psychiatric or dietary regimens depend upon the willpower of the patent to achieve the desired results. While weight loss may occur, the lack of willpower in patients often leads to ultimate failure. In response to the failure of dietary management, various surgical techniques have been developed and used to try to treat morbid obesity.
Methods that have been used in the prior art to treat morbid obesity include gastric bypasses and small-bowel bypasses. Stapling of portions of the stomach has also been used to treat morbid obesity. This includes both vertical and horizontal stapling and other variations trying to reduce the size of the stomach or make a small stoma opening. Many problems have been associated with the use of staples. First, staples are undependable; second, they may cause perforations; and the pouch or stoma opening formed by the staples becomes enlarged over time making the procedure useless.
Yet another method that has been developed is the placement of an inflatable bag or balloon into the stomach causing the recipient to feel "full." This procedure has been described in the patent to Garren et al U.S. Pat. No. 4,416,267 which discloses a device which displaces volume inside the stomach thereby reducing the size of the gastric compartment and which is easily removed. The balloon is inflated to approximately 80% of the stomach volume and remains in the stomach for a period of about three months or more. This procedure, although simple, has resulted in intestinal blockage, gastric ulcers, and even in one instance, death and fails to address the problems of potentially deleterious contact with the gastric mucosa which can result from leaving an inflated bag in the stomach for an extended period of time. Moreover, it also failed to produce significant weight loss for long periods of time.
A more promising method employs the placement of a band around a portion of the stomach thereby compressing the stomach and creating a stoma opening that is less than the normal interior diameter of the stomach for restricting food intake into the lower digestive portion of the stomach. Such a band has been described by Kuzmak et al in U.S. Pat. No. 4,592,339. It comprises a substantially non-extensible belt-like strap which constrictively encircles the outside of the stomach thereby preventing the stoma opening from expanding. Kuzmak et al also describe bands which include a balloon-like section that is expandable and deflatable through a remote injection site. The balloon-like expandable section is used to adjust the size of the stoma opening both intraoperatively and post-operatively. Such a device is referred to as a stoma-adjustable gastric band. Although the banding procedure has great promise due to its simplicity and the fact that it retains the desired diameter of the stoma opening, there have been problems in obtaining a proper sized stoma opening. Kuzmak, in U.S. Pat. No. 4,696,288, describes a calibrating apparatus and method for using with a gastric banding device. The calibrating apparatus facilitates controlling the size of the stoma with the gastric band.
Complications have been observed with both inflatable and non-inflatable gastric bands. In particular, obstruction of the stoma from edema and migration of the band has been observed. Such edema-caused obstruction of the stoma may be due to excessive vomiting. In these cases, the stoma must be enlarged either by deflating the expandable portion of a band or by removing the band altogether.
Until now, following implantation, the only way to remove a gastric banding device is by major surgery. Thus, while it is possible to vary the pressure on the exterior wall of the stomach by injection or removal of fluid into or out of a remote injection port, it is necessary to perform major surgery to remove prior art gastric bands. It is desirable to provide a gastric banding device with means thereon for removal of the band without the necessity for major surgery. A gastric band with such means for removal is referred to hereinafter as a reversible gastric band.